Thick vs. Thin Acellular Dermal Matrix (ADM)

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Thin ADM; Procedure: Thick ADM

• Registration Number: NCT03392038
• Lead Sponsor: University of Louisville

Brief Summary

To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2017-12-31
• Study First Submitted QC: 2017-12-31
• Study First Posted: 2018-01-05
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 18 years of age.

Exclusion Criteria

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thin ADM	Thin ADM	Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)
Thick ADM	Thick ADM	Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)

Primary Outcome Measures

Name	Time	Method
Percent root coverage	Six months	Between 0 and 100%

Secondary Outcome Measures

Name	Time	Method
Creeping Attachment	Six months	Amount in millimeters

Trial Locations

Locations (1)

Graduate Periodontics, UofL School of Dentistry; 🇺🇸 Louisville, Kentucky, United States